LCD for Continuous Positive Airway Pressure System (CPAP) (L11528)

 

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Contractor Information

Contractor Name 

NHIC 

Contractor Number 

16003 

Contractor Type 

DME MAC 

 

LCD Information

LCD ID Number 

L11528 

 

LCD Title 

Continuous Positive Airway Pressure System (CPAP) 

 

Contractor's Determination Number 

CPAP20080101 

 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.  

 

CMS National Coverage Policy 

CMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1, Section 240.4 

 

Primary Geographic Jurisdiction 

Connecticut
District of Columbia
Delaware
Massachusetts
Maryland
Maine
New Hampshire
New Jersey
New York - Entire State
Pennsylvania
Rhode Island
Vermont
 

 

Oversight Region 

Region III
 

 

 

Original Determination Effective Date 

For services performed on or after 10/01/1993  

 

Original Determination Ending Date 

 

 

Revision Effective Date 

For services performed on or after 01/01/2008  

 

Revision Ending Date 

 

 

Indications and Limitations of Coverage and/or Medical Necessity 

For any item to be covered by Medicare, it must: 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

INITIAL COVERAGE:

A single level continuous positive airway pressure (CPAP) device (E0601) is covered if the patient has a diagnosis of obstructive sleep apnea (OSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

1) The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour, or

2) The AHI is from 5 to 14 events per hour with documented symptoms of:

a) Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,

b) Hypertension, ischemic heart disease, or history of stroke.

If a claim for a CPAP device (E0601) is submitted and the criteria above have not been met, it will be denied as not medically necessary.

For the purpose of this policy, polysomnographic studies must be performed in a facility based sleep study laboratory, and not in the home or in a mobile facility. These labs must be qualified providers of Medicare services and comply with all applicable state regulatory requirements.

For the purpose of this policy, polysomnographic studies must not be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0601 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of an E0601 device beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device.

If the above criterion is not met, continued coverage of an E0601 device and related accessories will be denied as not medically necessary.

ACCESSORIES:

Accessories used with an E0601 device are covered when the coverage criteria for the device are met. If the coverage criteria are not met, the accessories will be denied as not medically necessary.

The following table represents the usual maximum amount of accessories expected to be medically necessary:

A4604 – 1 per 3 months
A7027 - 1 per 3 months
A7028 – 2 per 1 month
A7029 – 2 per 1 month
A7030 – 1 per 3 months
A7031 – 1 per 1 month
A7032 - 2 per 1 month
A7033 – 2 per 1 month
A7034 - 1 per 3 months
A7035 - 1 per 6 months
A7036 - 1 per 6 months
A7037 - 1 per 3 months
A7038 - 2 per 1 month
A7039 - 1 per 6 months
A7046 – 1 per 6 months

Quantities of supplies greater than those described in the policy as the usual maximum amounts, in the absence of documentation clearly explaining the medical necessity of the excess quantities, will be denied as not medically necessary.

Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered E0601 device. 

 

Coverage Topic 

Durable Medical Equipment
 

 

Coding Information

CPT/HCPCS Codes 

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service.
KX - Specific required documentation on file.

EQUIPMENT

E0601

CONTINUOUS AIRWAY PRESSURE (CPAP) DEVICE

ACCESSORIES

A4604

TUBING WITH INTEGRATED HEATING ELEMENT FOR USE WITH POSITIVE AIRWAY PRESSURE DEVICE

A7027

COMBINATION ORAL/NASAL MASK, USED WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7028

ORAL CUSHION FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, EACH

A7029

NASAL PILLOWS FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, PAIR

A7030

FULL FACE MASK USED WITH POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7031

FACE MASK INTERFACE, REPLACEMENT FOR FULL FACE MASK, EACH

A7032

CUSHION FOR USE ON NASAL MASK INTERFACE, REPLACEMENT ONLY, EACH

A7033

PILLOW FOR USE ON NASAL CANNULA TYPE INTERFACE, REPLACEMENT ONLY, PAIR

A7034

NASAL INTERFACE (MASK OR CANNULA TYPE) USED WITH POSITIVE AIRWAY PRESSURE DEVICE, WITH OR WITHOUT HEAD STRAP

A7035

HEADGEAR USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7036

CHINSTRAP USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7037

TUBING USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7038

FILTER, DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7039

FILTER, NON DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7044

ORAL INTERFACE USED WITH POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7045

EXHALATION PORT WITH OR WITHOUT SWIVEL USED WITH ACCESSORIES FOR POSITIVE AIRWAY DEVICES, REPLACEMENT ONLY

A7046

WATER CHAMBER FOR HUMIDIFIER, USED WITH POSITIVE AIRWAY PRESSURE DEVICE, REPLACEMENT, EACH

E0561

HUMIDIFIER, NON-HEATED, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

E0562

HUMIDIFIER, HEATED, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

 

 

ICD-9 Codes that Support Medical Necessity 

Not specified.

 

 

 

Diagnoses that Support Medical Necessity 

Not specified. 

 

ICD-9 Codes that DO NOT Support Medical Necessity 

Not specified.

 

 

 

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation 

 

 

Diagnoses that DO NOT Support Medical Necessity 

Not specified. 

 

General Information

Documentation Requirements 

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available to the upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, documentation supporting the medical necessity for the higher utilization must be available upon request.

Proper use of the KX modifier is discussed below. The KX modifier must not be used on claims submitted until the requirements outlined in the documentation section have been met.

INITIAL COVERAGE (FIRST THREE MONTHS):

On claims for the first through third months, suppliers must add a KX modifier to codes for equipment (E0601) and accessories only if all of the criteria in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy ("Initial Coverage") have been met.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

On the fourth month’s claim (and any month thereafter), the supplier must add a KX modifier to codes for equipment (E0601) and accessories only if both the "Initial Coverage" criteria and the "Continued Coverage" criteria in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy have been met. Suppliers must maintain documentation in their records that these criteria have been met and this must be available upon request.

If the supplier does not obtain information that the beneficiary is continuing to use the CPAP device in time for submission of the fourth or succeeding months’ claims, the supplier may still submit the claims, but a KX modifier must not be added. However, if the supplier chooses to hold claims for the fourth and succeeding months until they determine that the beneficiary is continuing to use the device, those claims may then be submitted with the KX modifier. 

 

Appendices 

A respiratory cycle is defined as an inspiration, followed by an expiration.

Polysomnography is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), and a submental electromyogram (EMG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

Apnea is defined as the cessation of airflow for at least 10 seconds documented on a polysomnogram.

Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep without the use of a positive airway pressure device, reported by polysomnography using actual recorded hours of sleep (i.e., the AHI may not be extrapolated or projected). 

 

Utilization Guidelines 

Refer to Indications and Limitations of Coverage and/or Medical Necessity. 

 

Sources of Information and Basis for Decision 

 

 

Advisory Committee Meeting Notes 

 

 

Start Date of Comment Period 

04/30/1993 

 

End Date of Comment Period 

06/14/1993 

 

Start Date of Notice Period 

08/01/1993 

 

Revision History Number 

CPAP011 

 

Revision History Explanation 

3/1/2008- In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC NHIC (16003) LCD L11528 from DME PSC TriCenturion (77011) LCD L11528.

Revision Effective Date: 01/01/2008
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added: Usual maximum quantity parameters for new codes A7027, A7028, A7029
HCPCS CODES:
Added: A7027, A7028, A7029
Removed: K0553, K0554, K0555

Revision Effective Date: 07/01/2007
INDICATIONS AND LIMITATIONS OF COVERAGE:
Removed: DMERC references.
Revised: Usual maximum quantity parameter for A7037.
Added: Usual maximum quantity parameters for new HCPCS codes – K0553, K0554 and K0555.
HCPCS CODES AND MODIFIERS:
Added: K0553, K0554 and K0555
DOCUMENTATION REQUIREMENTS:
Removed: DMERC references

06/01/2007 - In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TriCenturion (77011) from DMERC Tricenturion (77011).

Revision Effective Date: 01/01/2006
HCPCS CODES:
Added: A4604
Revised: A7032, A7033
INDICATIONS AND LIMIITATIONS OF COVERAGE:
Accessories:
Added frequency guideline for A4604, A7030 and A7046
Added clarification regarding Full Face Mask Seals (A7031)
DOCUMENTATION:
Revised requirements for documenting excess quantities of supplies.
APPENDICES:
Revised definition of apnea-hypopnea index (AHI) to reflect NCD.

Revision Effective Date: 01/01/2005
HCPCS CODES AND MODIFIERS:
Added code A7045
APPENDICES:
Clerical correction to move definitions from Policy Article to LCD Clarified calculation of AHI

Revision Effective Date: 07/01/2004
LMRP converted into LCD and Policy Article
INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:
Clarified how accessories are denied when medical necessity is not met.

Revision Effective Date: 01/01/2004
HCPCS CODES AND MODIFIERS:
Crosswalked codes K0268 and K0531 to E0561 and E0562, respectively.Added new code A7046
OTHER COMMENTS:
Revised the definition of AHI to require a minimum of two hours of recording time without the use of the device rather than two hour of recorded sleep.

Revision Effective Date: 04/01/2003
HCPCS CODES AND MODIFIERS:
Added: A7030 – A7039, A7044, EY
Discontinued: K0183 – K0189
INDICATIONS ANDLIMITATIONS OF COVERAGE:
Adds standard language concerning coverage of items without an order.
Updated utilization table to incorporate new A codes which were crosswalked from K codes.
Removed reference to RDI in definitions section.
DOCUMENTATION REQUIREMENTS:
Adds standard language concerning use of EY modifier for items without an order.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

07/01/2002 – Revised language regarding who is a qualified provider of polysomnographic studies.

04/01/2002 – Updated Coverage and Payment Rules section to reflect National Coverage Decision to cover CPAP based on apnea-hypopnea index. Eliminated Certificate of Medical Necessity requirement. Added KX modifier to indicate coverage criteria met. Revised verbiage of HCPCS code K0184. Allowed coverage of either heated or non-heated humidifier with a covered CPAP device.

10/01/1995 – Added HCPCS codes for accessories.

12/01/1993 – Corrected typo from HAO to HA0 in the Documentation section.

 

Last Reviewed On Date 

 

 

Related Documents 

Article(s)
A19815 - Continuous Positive Airway Pressure (CPAP) Devices – Policy Article – Effective January 2008

 

LCD Attachments 

There are no attachments for this LCD

 

Article for Continuous Positive Airway Pressure (CPAP) Devices – Policy Article – Effective January 2008 (A19815)

Top of Form

Bottom of Form

 

Contractor Information

Contractor Name 

NHIC 

Contractor Number 

16003 

Contractor Type 

DME MAC 

 

Article Information

Article ID Number 

A19815 

Article Type 

Article

Key Article 

Yes

Article Title 

Continuous Positive Airway Pressure (CPAP) Devices – Policy Article – Effective January 2008 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

Primary Geographic Jurisdiction 

Connecticut
District of Columbia
Delaware
Massachusetts
Maryland
Maine
New Hampshire
New Jersey
New York - Entire State
Pennsylvania
Rhode Island
Vermont
 

Original Article Effective Date 

07/01/2004

Article Revision Effective Date 

01/01/2008

Article Text 

CODING GUIDELINES

A continuous positive airway pressure (CPAP) device (E0601) delivers a constant level of positive air pressure (within a single respiratory cycle) by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

For auto-titrating CPAP devices use HCPCS code E0601.

Accessories are separately reimbursable at the time of initial issue and when replaced.

A4604 describes tubing used with a heated humidifier which and has a heated wire running the length of the tubing. It is designed for use with a positive airway pressure device and a non-invasive interface – i.e., nasal or face mask, nasal cannula, or oral interface.

Code A7032 is used for a replacement nasal mask interface that goes around the nose, but not into the nostrils. The unit of service for this code is “each”.

Code A7033 is used for a replacement nasal cannula-type interface. This interface extends a short distance into the nostrils. The unit of service for this code is “pair”. For some products, there are two physically separate cushions or “pillows” – one for each nostril. Two cushions/ pillows equals one unit of service of A7033. For other products, the interface is a single piece with two protrusions that extend into the nostrils. One of these interfaces equals one unit of service of A7033.

A7027 (Combination oral/nasal mask, used with continuous positive airway pressure device, each) is a two piece system with separate elements for oral and nasal use.

Suppliers should contact the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.

Coverage Topic 

Durable Medical Equipment
 

 

Coding Information

No Coding Information has been entered in this section of the article.

 

Other Information

Revision History Explanation 

3/1/2008- In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC NHIC (16003) Article A19815 from DME PSC TriCenturion (77011) Article A19815.

Revision Effective Date: 01/01/2008
CODING GUIDELINES:
Substituted: New code A7027

Revision Effective Date: 07/01/2007
CODING GUIDELINES:
Added: Narrative definition for new HCPCS code K0553.

06/01/2007 - In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this article was transitioned to DME PSC TriCenturion (77011) from DMERC Tricenturion (77011).

Revision Effective Date: 01/01/2006
CODING GUIDELINES:
Added definitions for tubing with a heated wire (A4604) and replacement nasal interfaces (A7032, A7033).

Revision Effective Date: 01/01/2005
Clerical correction to move definitions from Policy Article to LCD

Revision Effective Date: 07/01/2004
LMRP converted into LCD and Policy Article

 

Related Documents 

 

LCD(s)
L11528 - Continuous Positive Airway Pressure System (CPAP)